MannKind Corporation (NASDAQ:MNKD) Q3 2023 Earnings Call Transcript

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On the 201, it’s just making the clinical supplies which are in the process right now and getting those up on stability in terms of getting the three-month data we need to file that IND. So both of those are on track. It’s mainly around just making sure the manufacturing is up and running. Unfortunately, the team that’s making 201 had to make 101 on top of everything else. And so you know, they’re stacked on top of each other, but they’re working hard to get them both ready for IND filing. So those are the main things that are the last steps here. All the talks and everything else pretty much is ready to go. The Phase 2/3 design, we actually have an upcoming FDA meeting where I’ll provide more clarity after that, because we’re going to the FDA to try to change a few things we had previously — were focused on looking at the new — our case data just came out with their quality of life as well as some of the dosing.

We think there’s a way to continue to streamline these trials. As you may or may not know, we hired a new head of R&D, Dr. Burkhard, and he joined us back in May. So we’ve taken a fresh look at all the programs, the trials, the FDA feedback, and there’s few things we thought could be a little bit clear and ensure the trials go as smoothly as possible, as fast as possible. So we’ll get that feedback in the next month and we’ll share those updates, hopefully JP Morgan on the official trial design that we’re comfortable with.

Andreas Argyrides: Okay, great. Appreciate the color and congrats on all the progress. Thanks.

Michael Castagna: Thank you.

Steven Binder: Thank you.

Operator: Thank you. I’m showing no further questions at this time. I would like to turn it back to Michael Castagna, CEO, for closing remarks.

Michael Castagna: Just thank you, everyone. I think you can see we’ve made a lot of progress. We continue to grow our revenue, we continue to help more patients, and we continue to move the pipeline forward. And really our goal to improve our mission, to give people control of their health and the freedom to live their life. As you look at each of our targets, these people are really suffering. And in some cases, they have three to five years to live. And so every day counts to get these patients, our treatments as soon as possible, safely and effectively in the clinical trials to hopefully get them to the market. Thank you, everyone, for everything. We look forward to closing out the year strong and we’ll provide continued updates as news comes in. Thank you again.

Operator: This concludes today’s conference call. Thank you for participating. And you may now disconnect.

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